An Analysis of the Regulatory and Legal Aspects of Patient Package Inserts
Tài liệu tham khảo
1976
21 U.S.C. § 321 (m)
21 C.F.R. § 310.501
Weibart, 1977, Potential distribution problems—1, Drug Inf. J., 11, 455
1951, United States v 8 Cartons, containing “Plantation ‘The Original,’ ”, 103
1948, Kordel v United States, Sup. Ct., 69, 106
Ibid, at. , 110
1948, United States v Urbeteit, Sup. Ct., 69, 112
1968, United States v An Article of Device, Diapulse Manufacturing Corporation of America, Sup. Ct, 389, 2059
e.g., W.A.C. 360-16-250
21 U.S.C. § 331 (k)
1969, The Founding Church of Scientology of Washington v United States, 409, 1146
21 C.F.R. § 310.501 (6)
21 U.S.C. § 353 (2)
21 U.S.C. § 352 (f) (1)
21 U.S.C. § 352 (f) (2)
21 U.S.C. § 321 (n)
21 U.S.C. § 331 (k)
W.A.C. 360-16-250; N.J.A.C. 13:39-6.3
21 C.F.R. 201 .100
1977, Food and Drug Administration, Compliance Policy Guides, Guide, 7132, 28
1976, Fed. Reg., 41, 43108
1975, Fed. Reg., 40, 15392
1961, HEW Memo No. DAO #5, from Division of Advisory Opinions to Directors of Districts, 7
1975, Fed. Reg., 40, 15392
21 U.S.C. § 355
1976, Fed. Reg., 41, 43108
1976, Food and Drug Administration, Compliance Policy Guides, Guide, 7132, 09
1976, Fed. Reg., 41, 43108
1974, C.F.R., 21, 310
1976, 530, 1054
